Identification of Medicinal Products (IDMP) implementation greatly varies across organizations and regulatory jurisdictions, which impacts drug safety and pharmacovigilance. To ensure that organizations around the world can use universal semantic interoperability based on FAIR data principles, the Pistoia Alliance has built an IDMP Ontology (IDMP-O Release 1), augmenting existing ISO IDMP standards set by the European Medical Agency. This project earned them the Innovative Practices Award at April’s Bio-IT World Conference & Expo.
During Bio-IT World, Christian Baber, chief portfolio officer at Pistoia Alliance, and Sheila Elz, master data manager at Bayer AG, presented the IDMP Ontology in detail and elaborated on how the Pistoia Alliance brought together 11 pharmaceutical companies—Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie, and Pfizer, as well as representative from EDM Council, ACCURIDS, OSTHUS, and Chemantics—to collaborate on this project. The project is intended to help everybody benefit from IDMP standardization, including improving pharmacovigilance, enabling cross-border prescriptions, and helping the prevention of medication shortages through interoperability with manufacturers.
IDMP standards play a critical role in giving healthcare providers and manufacturers reliable information about medicinal products, regardless of their brand name. This is to ensure that medications are made to the correct specifications and can help healthcare providers with a more efficient way to identify and prescribe safe alternatives if one brand becomes unavailable. Despite this, IDMP implementations are not fully standardized, which has resulted in inconsistencies of interpretations amongst the industry, caused misunderstandings, slowed development, and hindered progress.
A key issue behind the lack of standardization comes from different countries having different drug information and medicinal product dictionaries. The large volume of information is also tedious and complex to sift through for pharmaceutical companies, drug manufacturers, and regulators. A shared data language can eliminate several different identifiers for the same object.
The Pistoia Alliance’s IDMP Ontology aims to facilitate cross-functional and industry-wide unified implementations of the IDMP standard. By serving as a common language, the IDMP Ontology enables effective communication and common understanding among stakeholders, as well as provides a robust data backbone for organizations to automate IDMP data management and standardize data aggregation from different sources.
The IDMP Ontology transcends functional silos, providing answers to product-related inquiries that bridge across clinical development, manufacturing, supply chain management, and data analytics. Meanwhile, the IDMP standards are a set of five PDF documents, which transforms them into a machine-readable format. Because alignment within the industry, regulatory authorities, and standards development organizations are paramount, an iterative development approach was adopted to demonstrate tangible business value through real-world examples implemented by the project team.
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